AU2003205020B2 - Self administered lymphatic massage - Google Patents

Description

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1 SELF ADMINISTERED LYMPHATIC MASSAGE FIELD OF THE INVENTION THIS invention relates to self administered lymphatic massage and in particular but not limited to self administered treatment for chronic primary or secondary leg lymphoedema and to a therapeutic pad suitable for that and other similar treatments.

BACKGROUND TO THE INVENTION Home based use of management aids for chronic non life threatening disorders such as lymphoedema can be an acceptable mainstay for those persons who are unable to attend clinics or practitioners or who live in rural or remote areas. Home management can supplement other forms of more intensive treatment from practitioners in a cost-effective manner which also provides control and empowerment to the affected individual. Some 30% of men and women who undergo unilateral or bilateral groin and/or abdominal clearance develop unilateral or bilateral lymphoedema at a time after the surgery and/or radiotherapy whilst another 30% suffer some forms of subjective inconvenience such as pains, heaviness, tension, problems with range of movement, an inability to undertake activities of daily living and associated problems with quality of life. Therefore early and continuing control and management of this condition is of prime importance. Previous reports have suggested that multidirectional vibration therapy may improve tissue health through facilitating a reduction in tissue congestion (oedema) and improved wound healing butto date there has not been any systematic approach for self administration. The alternative is to employ a massage therapist and of course the costs are much higher than an effective self administered regime.

It is an object of the present invention to provide an effective self administered regime.

OUTLINE OF THE INVENTION in one aspect the present invention resides in a self administered therapeutic lymphatic drainage massage pad employing a vibratory source, preferably in the form of a motor having a rotating shaft adapted to rotate eccentrically, the shaft being journalled in flexible bearings so that eccentricity 2 causes rotary vibration, a vibratory cushion assembly driven by the vibratory source, the cushion assembly having an applicator surface and communicating the vibration from the vibratory source along the cushion assembly and delivering vibration therapy to a user through the applicator surface, the amplitude and frequency being selected to effect lymphatic drainage therapy over the applicator surface in contact with the user.

The vibration is typically imparted to a housing in which a motor is housed. The motor housing is typically connected to one end of the cushion assembly, the cushion assembly comprising a frame covered by cushion material the frame being connected to the housing for operative conduction of the rotary vibration to the applicator surface. The rotary vibration is transmitted from the housing to the frame in the cushion and then to the user who places a body part on the cushion to receive the conducted vibrations.

The pad is preferably of the type described in US Patent No. 3,019,785 to Eiden entitled Vibratory Massage Cushion and modified to provide to mimic lymphatic drainage therapyaccording to the following description. The disclosure of US Patent No. 3,019,785 is incorporated herein by reference. Reference should be made to this patent which exemplifies the type of construction that may be employed to enable transmission of a rotary vibration to an application surface. This type of massager may be purchased from Niagara Therapy Manufacturing Limited, pertinent address being as follows Niagara Therapy Manufacturing (Aust.) Pty Ltd, 16/18 Josephine Street, Loganholme, Brisbane, Queensland, Australia; Niagara of America Inc., 703 Westover Street, Gastonia, N. C. 28056, United States of America; and Niagara Manufacturing Ltd., Colmendy Industrial Estate, Ryl Road, Denbigh, Clwyd, LT 165TS, United Kingdom and known as the "Niagara Thermo Cyclopad".

This pad is for general use and is not designed for any specific therapeutic application. In particularthe pad operates at higher frequencies than proposed in the present invention and is specifically marketed for its proprietary "Cycloid Polymodulation" where the frequency is automatically modulated.

The present invention optimises clinical effectiveness by applying a hitherto unexpected application of this type of device at a low frequency. It will ID 3

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0therefore be appreciated that although the same type of construction may be employed the pad of the present invention is a different pad.

In one aspect there is provided a method of self administered lymphatic 0massage employing a massage pad operating at low frequency to mimic lymphatic drainage massage and having a rotary vibratory source and a vibratory otransmitter located within the pad and communicating with the rotary vibratory source, the treatment method comprising the steps of application of the pad to othe torso and subsequently to the legs.

In another aspect there is provided a method of self administered massage employing a massage pad operating at low frequency to mimic lymphatic drainage massage and having a rotary vibratory source and a vibratory transmitter located within the pad and communicating with the rotary vibratory source, the treatment method comprising the steps of:application of the pad to the lower back, with the body position lying face up, subsequently application of the pad on the abdomen with the body position lying face down, subsequently application of the pads on the top of thighs body position lying down, subsequently application of the pad underthighs, body position lying face up, and subsequently application of the pad under calves, body position lying face up.

The total application time may vary as may the order of application to any part, typically the total time is 1 hour evenly applied to each part.

Preferably, the vibratory source is set to a frequency of not more than Hertz and at a frequency and amplitude conceived to mimic manual lymphatic Sdrainage massage. The objective being to clear lymph nodes and vessels in the abdomen and lower back before working downward and clearing vessels in the thigh and calves.

Accordingly, in another aspect there is provided a massage pad assembly having a rotary vibratory source and a vibratory transmitter located within the pad and communicating with the rotary vibratory source, the assembly being configured to mimic manual lymphatic drainage massage when applied to a patient. Preferably the pad is driven by a motor having a central shaft and an 0eccentric mass located mass on a projecting portion of the shaft.

The applicant has carried out clinical trials in relation to this process with o a frequency setting of 47 hertz in the prototype unit but is of the view that lower frequencies may be more effective than the results depicted in the clinical trials oset out below. It is to be noted that in addition to the present methods not having been used before an unexpected result of the treatment was a reduction in body mass in relation to the treatment of chronic primary and secondary leg lymphoedema.

BRIEF DESCRIPTION OF THE DRAWINGS In order that the present invention maybe more readily understood and be put into practical effect reference will be made to the accompanying schematic drawing of a pad and the following report arising from clinical trials.

METHOD OF PERFORMANCE The attached drawing Figure 1 illustrates a pad assembly comprising a drive motor housing 11 connected to a vibratory frame 12 located inside a cushion assembly 13 shown in phantom. The cushion assembly is substantially as described in US patent 3,019,785. A d.c. motor 14 drives a shaft 15 which carries a weight 16 so the shaft is unbalanced. The shaft travels in self-centring bearings and is driven in this embodiment at a fixed therapeutic frequency of 47Hz to mimic manual lymphatic drainage massage. The frequency may be a specialised selectable addition to the available frequency and operational modes available on current commercial units such as the Niagara Cyclopad. The rotary vibration as applied to a patient at the delivery is termed "cycloid vibration therapy".

Reference will now be made to clinical trials.

Methods All participants used the massage pad as outlined below for a total time of one hour distributed evenly across the 5 areas. This regimen was designed to simulate the sequence used during a lymphoedema drainage massage such as ID 0 manual lymphatic drainage (although it is acknowledged that the exact nature cannot be mimicked). The aim being to clear lymph nodes and vessels in the Sabdomen and low back before working downward and clearing vessels in the Sthighs and calves.

0 0 In 0 10 rcl Pad position Body position*: 1 Pad at low back Lying face up 2 Pad on abdomen Lying face down 3 Pad on top of thighs Lying face down 4 Pad under thighs Lying face up 5 Pad under calves Lying face up participants position when using the pad Measurement All patients were measured prior to entry into the study, at 1, 2, and 3 week and then one month after cessation of the use of the massage pad.

Limb Circumference and Volumes Patients total leg limb volume and circumference was measured using a Perometer@ which measures limb circumference at 4mm intervals and calculates limb volume. This equipment's accuracy and reproducability has been validated by independent researchers. (Stanton et al 1997, 2000, Tierney et al 1996).

Extracellularand Intracellularfluids, Fat and othercomposition parameters Bio-impedance is being increasingly used as an early indicator of change in oedematous/lymphoedematous limbs with recent studies confirming the validity and accuracy of the process. (Thomas et al 1992, Cornish 2000, Cornish et al 1996,2001, Piller and Cornish, 2000) Patients' Body composition (including intra cellular and extra cellular fluid and segmental fluid distribution in the legs and trunk) was measured using the In Body bioimpedance system. (Cha et al 1997).

This system works by passing a number of different frequencies of electrical current (5 500Hz) through the body from one electrode to one of the other 7 electrodes and while this occurs the resistance to flow is determined. Since different frequencies take different paths by mathematical modelling it is possible to determine a range of body parameters such as fluids, fat and muscle masses.

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0 Fibrotic Induration: As an oedema or lymphoedema progresses the fluid may change to fibrous tissues as a consequence of the sub clinical inflammatory processes which occur. Any fibre build up can significantly impinge on lymphatic drainage, so it is very important to detect this fibrous tissue and to see if treatment has an effect oon it. Build up of fibrous tissue was measured using a tonometer, which uses defined weight to measure the resistance of tissues, with greater resistance 0indicating fibrotic induration. (Casley-Smith, et al 1993, Liu and Olszewski, 1992, oClodius et al, 1976) Fibrotic induration was measured at three sites on each 0 10 limb, these being the calf and upper anterior and posterior thigh. 1 Subjective Measures: Prior to and at each assessment participants were asked to rate their experience of 20 aspects of quality of life and activities of daily living, using a 10 point Likert rating scale. Their experience of pain was measured using the short form McGill Pain Questionnaire (MPQ). They also rated 10 symptoms commonly associated with chronic swelling such as tightness, heaviness, cramps, skin dryness burning feelings etc using a 10 point Likert scale. (1 no problem or issue to 10 worst imaginable problem or issue). Perception of performance of, and satisfaction with, valued occupations was measured using the Canadian Occupational Performance Measure (COPM). Participants were also asked if they experienced any side effects while using the massage pad. The very significant results from these aspects of the study are to be reported at the World Occupational Therapy Congress in Stockholm in 2002.

Analysis Data was analysed using SPSS. Median analysis was performed where data was not normally distributed.

Results: Leg Volumes Leg volume (mls) showed good clinical change after three weeks of massage pad use. Affected leg size continued to decrease when measured at the four-week post treatment follow up, as demonstrated in the table below.

Initial Week 1 Week 2 Week 3 Follow up Number 31 31 30 29 27 Missing 2 2 3 4 6 Median 7215.0000 7194.0000 7311.0000 6983.0000 6661.0000 Std 2230.8670 2335.8002 2269.5067 2147.4825 2277.6983 Deviation Percentiles: 25 h 5906.0000 5657.0000 6001.0000 5931.5000 5322.0000 8875.0000 9213.0000 9244.5000 8793.2500 7984.0000 Affected leg volume clinical changes Affected leg size Sample size Number with less Number with less time frame swelling swelling by 150ml 3 weeks 28 20 6 (21.4%) 4 week follow up 27 15(55.5%) 6 (22.2%) Leg fluids. Statistically significant results were obtained for affected leg fluid after the first week of massage pad use Results for weeks 1 and 3 for affected leg fluid were clinically significant, while at the four week follow up 55.5% of this group (n=27) had less fluid than at the third week measurement, with 3 participants having a decrease of 480ml. Below is a table of affected leg fluid (ICF+ECF), showing changes in litres Initial Week I Week 2 Week 3 Follow up Number 33 33 31 30 27 Median 6.2050 6.0300 6.1100 6.1250 6.0500 Std 1.5788 1.5132 1.5965 1.4987 1.3959 Deviation Percentiles: 25 th 4.7550 4.7625 4.8400 4.6200 4.6500 th 7.2175 7.1475 7.0500 7.0975 6.9500 Affected leg fluid Clinical changes Leg fluid time Sample size Number with less Number with less frame fluid fI fluid 200ml 1% 1 week 33 21 9 (27.2%) 3 weeks 30 15 8 (26.6%) Truncal fluids. Total trunk fluid decreased over three weeks of massage pad use after initially increasing. Results for the second and third weeks of massage pad use were clinically significant. At the four week follow up measurement trunk 8 fluid had increased again indicating that the massage pad had had a significant effect on truncal fluids. Below is a table showing changes in Trunk fluids (ICF+ECF), litres.

Initial Week I Week 2 Week 3 Follow up Number 33 33 31 30 27 Missing 0 0 2 3 6 Median 15.6000 15.7000 15.4000 15.4500 15.8000 Std 3.9437 3.9845 4.0975 3.7098 3.7873 Deviation Percentiles: 25t 13.4000 13.2500 13.6000 13.4000 13.4000 18.8000 18.8000 20.0000 18.8500 18.6000 Trunk fluid clinical changes Total body Extracellularfluid. These values also showed some clinical change after two and three weeks of massage pad use, however these changes were not maintained at the 1 month follow up. Below is a table of the changes in the total extracellular fluid (litres) Initial Week 1 Week 2 Week 3 Follow up Number 33 33 31 30 27 Missing 0 0 2 3 6 Median 12.2000 12.0000 11.9000 12.0000 12.100 Std 2.8876 2.9384 3.1168 2.6595 2.598 Deviation Percentiles: 25 t h 10.5500 10.5000 10.5000 10.5250 10.500 14.0000 13.7000 14.6000 13.7000 13.600 Median total fluids whole body clinical changes ECF time frame Sample size Number with fluid Number with fluid change change by 2 200ml 2 weeks 31 15 smaller 11 smaller 3 weeks 30 .17 smaller 12 smaller

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0 0 cI tc 1 0 ci 4 week follow up 27 15 bigger 1 10 bigger Fibrotic induration. Softness in the calves increased throughout three weeks of using the massage pad. Minimal changes were recorded at the anterior or 5 posterior thigh. Below is a table showing changes to resistance to compression (in arbitrary units)-for the calf 0 Initial Week 1 Week 2 Week 3 Follow up Number 33 33 31 30 27 Missing 0 0 2 3 6 Mean 4.2614 4.2924 4.2718 4.5092 4.3574 Std error of .1841 .2006 .2099 .1855 .1937 mean

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Body composition. The lymphoedema group experienced a decrease in body fat mass of 2.2kg p=0.859) after three weeks of massage pad use. At the follow up measurement they had still a decrease of 1.0kg of initial reading, p=0.531). After three weeks massage pad use this group had a decrease in percentage body fat of 0.55% (p=0.772) which had returned to the same as initial reading at the follow up measurement. Body mass index decreased by 0.3 kg/m 2 p=0.978) after three weeks of massage pad use and had returned to the same as initial reading at the follow up measurement. Basal metabolic rate increased by 40.45 Kcal p=0.783) after three weeks massage pad use.

It was still increased by 29.4 Kcal p=0.969) at the follow up measurement.

Subjective results: Symptoms: Participants reported statistically significantly fewer symptoms for 8 of the 10 symptoms measured throughout the trial. Significant changes were reported after both the first week and the third week of massage pad use for tightness, heaviness, cramps pins and needles, skin dryness and size difference (perceived amount of swelling). Reported pain significantly decreased after the first week of massage pad use, however this was not maintained in the following weeks. Reported mobility significantly increased after three weeks of massage pad use. Symptoms which did not change significantly after use of the massage pad were burning feeling and perceived temperature difference.

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0Some 40% of the participants reported improvements in the fit of their clothing and shoes. Other significant comments included symptomatic improvement and a feeling of relaxation 0Side effects: Reported side effects were slight nausea, light-headedness, headaches and increased joint pain (in-patients with pre-existing joint oconditions)). None of which were particularly strong or clinically significant.

Participants with lymphoedema experienced'a good clinical decrease in 0leg volume after three weeks of cycloid vibration therapy and also when measured at the 1 month follow up. This maintenance of leg volume reduction may indicate a longer-term effect of the therapy. It is not clear however why leg volumes for this group increased in the short term (after one and two Weeks of therapy) before decreasing. Cycloid vibration therapy had a significant short-term effect on the amount of total leg fluids. Good clinical effects were also obtained after three weeks and at follow up, indicating a possible trend. Trunk fluid and extra cellular fluid also reduced by clinically significant amounts after cycloid vibration therapy, however these reductions were not maintained at the follow up. This fact suggests that ongoing use of the equipment is likely to produce a beneficial ongoing positive effect. Resistance to compression (fibrotic induration) at the calf was reduced after three weeks of vibration therapy, however this change was not maintained when measured at the follow up. This suggests that ongoing use of the equipment is likely to produce a beneficial ongoing positive effect. Body fat mass decreased by 2.2 kg after therapy and this group still had a 1 kg loss in body fat mass when measured at the follow up, which are clinically significant findings. Changes to body mass index, body fat mass weight and leg volume were associated in this group, indicating that the therapy may have had a systemic effect on these participants. These reductions are very relevant and exciting since body mass is one of the major exacerbating factors of lymphoedema and a reduction is likely to have significant benefit on the patient 's lymphatic system. It may also be beneficial for those with decreased mobility who can not undertake more strenuous exercise. The very significant subjective improvements in performance of valued daily activities improved (p=.000, n=33) and in patients satisfaction with performance of daily activities and in activities V0 11 0 0 of daily living (to be reported elsewhere) show great benefits even after three weeks of Niagara massage pad use.

SReferences Bates, DO, Levick, JR and Mortimer, PS 1994. Quantification of rate and depth of pitting in human oedema using an electronic tonometer. Lymphology 27 159- S172 SCasley-Smith, JR, Morgan, RW and Piller, NB 1993 Treatment of lymphoedema o of the arms and legs New England Journal of Medicine, 329 1158-1163 SCha, K Shin, S, Shon, C Choi, S and Wilmore, S 1997, Evaluation of segmental S 10 bio electrical impedance analysis for measuring muscle distribution J ICHPER, 11-14 Clodius L, Deak Piller N 1976 A new instrument for the evaluation of tissue tonometry in lymphoedema. Lymphology 9: Cornish B, Bunce I Ward L 1996 Bio-electrical impedance for monitoring the efficacy of lymphoedema treatment programs. Breast Cancer Research and Treatment 38: 169-76 Cornish, BH 2000 Bioelectrical impedance analysis revisited Lymphology 33 136-137 Cornish, BH Chapman, M Hirst, C, Mirolo, B, Bunce, IH Ward LC and Thomas, BJ 2001 Early diagnosis of lymphoedema using multi-frequency bioimpedance Lymphology 34 (1),2-11 Leduc, A Lievens, P and Dewald, J 1981, The influence of multidirectional vibrations on wound healing and regeneration of blood and lymph vessels.

Lymphology, 14, 179-185 Liu N, Olszewski W 1992 Use of tonometry to assess lower extremity lymphoedema. Lymphology 25: 155-8 Tierney S, Aslem M Rennie K 1996 Infrared opto-electronic volumetry, the ideal way to measure limb volume. Europ. J Vasc. Endovas Surg 12: 412-17 Piller, NB Goodear, M and Peter, D 1998 Lymphoscintigraphic Evidence supports the evidence of axillo-anastomotic pathways in a patient with chronic secondary leg lymphoedema subsequent to inguinal node clearance and radiotherapy. European J Lymphology 6(24) 97-100 0D 12

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0 Piller, NB and Clodius, L 1976 The use of a tissue tonometer as a diagnostic aid in extremity lymphoedema Lymphology 9 127-132 SPiller, NB and Cornish, B 2000 Bio-impedance and Tonometry Benefits and limitations as diagnostic tools in lymph and other oedemas. Proc Third Australian Lymphology Association Congress. 49-58 o Stanton, AWB, Badger, C, Sitza, J 2000 Non invasive assessment of the Slymphoedematous limb Lymphology 33 122-135 o Stanton, AWB, Northfield, JW, Holryod, B et al 1997 Validation of an Soptoelectronic limb volumeter (perometer) Lymphology 30, 77-97 Ci 10 Thomas, BJ, Cornish, BH and Ward, LC 1992 Bioelectrical impedance analysis for measurement of body fluid volumes: A review J Clin Eng. 17 505-510 Whilst the above has been given by way of illustrative example of the present invention many variations and modifications thereto will be apparent to those skilled in the art without departing from the broad ambit and scope of the invention as set out in the appended claims.

Claims (8)

1. A method of self administered lymphatic massage employing a massage pad operating at low frequencyto mimic lymphatic drainage massage and having 0, a rotary vibratory source and a vibratory transmitter located within the pad and communicating with the rotary vibratory source, the treatment method comprising othe steps of application of the pad to the torso and subsequently to the legs.

2. A self administered therapeutic lymphatic drainage massage pad when 0used in the method of claim 1 employing a rotary vibratory source, a vibratory ocushion assembly driven by the vibratory source, the cushion assembly having 0 10 a applicator surface and communicating the vibration from the vibratory source along the cushion assembly and delivering vibration therapy to a user through the applicator surface, the amplitude and frequency being selected to effect lymphatic drainage therapy over the applicator surface in contact with the user.

3. A self administered therapeutic lymphatic drainage massage pad according to claim 2 wherein the vibration is imparted to a housing in which a motor is housed, the motor housing being connected to one end of the cushion assembly, the cushion assembly comprising a frame covered by cushion material, the frame being connected to the housing for operative conduction of the rotary vibration to the applicator surface.

4. A self administered therapeutic lymphatic drainage massage pad according to claim 2 operating at a frequency of less that 50 Hz.

A self administered therapeutic lymphatic drainage massage pad according to claim 3 operating at a frequency of less that 50 Hz.

6. A method of self administered lymphatic massage according to claim lemploying a massage pad operating at low frequency to mimic lymphatic drainage massage and having a rotary vibratory source and a vibratory transmitter located within the pad and communicating with the rotary vibratory source, the treatment method comprising the steps of: application of pad to the lower back, with the body position lying face up, subsequently application of the pad on the abdomen with the body position lying face down, ND 14 O 0subsequently application of the pads on the top of thighs body position lying down, subsequently application of the pad under thighs, body position 0' lying face up, and subsequently application of the pad under calves, body position olying face up

7. A method of self administered lymphatic massage according to claim 1 0or claim 6 wherein the total application time is about 1 hour evenly applied to Seach part.

8. A method of self administered lymphatic massage according to any one of claims 1, 6 or 7 wherein the vibrator source is set to a frequency of not more than 50 Hertz.